MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-12-04 for DURASEAL, UNKNOWN XXX-DURASEAL manufactured by Integra Lifesciences Corp.
[129305466]
The device is not expected to be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[129305467]
A patient's daughter reported that an xxx-duraseal was used on an unspecified neck surgery. During the procedure, an artery was nicked so the doctors used duraseal to seal it. The patient was told that the glue was supposed to dissolve. However, scans showed that the glue was crammed that caused the patient in pain. The duraseal was putting pressure on the nerve so the patient could not work or do anything.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00045 |
| MDR Report Key | 8130805 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-12-04 |
| Date of Report | 2018-11-12 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2018-12-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORP |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURASEAL, UNKNOWN |
| Generic Name | DURASEAL CRANIAL |
| Product Code | NQR |
| Date Received | 2018-12-04 |
| Catalog Number | XXX-DURASEAL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP |
| Manufacturer Address | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-04 |